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Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-sarcal Radiculopathy

Primary Purpose

Lumbosacral Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mckenzie Extension Exercises
William Flexion Exercises
Sponsored by
Neuro Counsel Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbosacral Radiculopathy

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Males and females with age between 40-60 years Patients referred from neuro and orthopedic departments with diagnosed lumbosacral radiculopathy. Complaint of low back pain on walk, bending and after long sitting with positive slump test. Complaint of low back pain, and numbness and tingling in leg with positive SLR test Exclusion Criteria: • Lumbar Trauma Any other orthopedic and neurological conditions of hip and lumbosacral spine. Hip Fracture Malignancy

Sites / Locations

  • Isra niversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: Mckenzie Extension Prone press-ups Head life in prone Prone on elbow Prone on hands Prone on pillow

55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: William Flexion Single knee to chest Double knee to chest Straight Leg Raise Bridging Pelvic tilt

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
0 means no pain and 10 means worst pain ever felt
Flexi curve ruler
to measure the lumber cure
Bubble inclinometer
Measure the cure
King Health Questionnaire quality of life
lesser score means low quality of life and higher score means better quality of life

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
February 1, 2023
Sponsor
Neuro Counsel Hospital, Pakistan
Collaborators
National Institute of Rehabilitation Medicine, Islamabad, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05654428
Brief Title
Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-sarcal Radiculopathy
Official Title
Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-Sarcal Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
January 21, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuro Counsel Hospital, Pakistan
Collaborators
National Institute of Rehabilitation Medicine, Islamabad, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lumbosacral radiculopathy (LR) is among most common disorder caused due to irritation or compression of nerve pathway leading to symptoms of pain, numbness and tingling sensations along the nerve root. Lumbosacral radiculopathy consists at any lumbar region including L1-S1. Occurrence rate of Lumbosacral radiculopathy is 3-5% distributed equally in men and women affecting more men than women. It commonly occurs in late 40s in men and late 50s-60s in females. Men are more prone to develop lumbosacral radiculopathy due to mechanical disturbance during routine work.
Detailed Description
William flexion exercises: Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR). Mckenzie extension exercises: The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone A randomized controlled trial. Group 1 Group 2 55 patients 55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: Mckenzie Extension Prone press-ups Head life in prone Prone on elbow Prone on hands Prone on pillow New Intervention: William Flexion Single knee to chest Double knee to chest Straight Leg Raise Bridging Pelvic tilt Each exercise will be repeated 5 minutes with 10 seconds hold and 5 sec rest. The duration of intervention will be four weeks, 3 sessions a week on alternate days and total of 12 sessions will be given. Data will be collected in three phases Pre-Treatment at end of second week and at the completion of treatment time i.e end of 4th week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Control Trail with 2 Equal groups
Masking
Participant
Masking Description
Just Participants are unaware about which type of intervention they are being underwent.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: Mckenzie Extension Prone press-ups Head life in prone Prone on elbow Prone on hands Prone on pillow
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: William Flexion Single knee to chest Double knee to chest Straight Leg Raise Bridging Pelvic tilt
Intervention Type
Other
Intervention Name(s)
Mckenzie Extension Exercises
Intervention Description
The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone.
Intervention Type
Other
Intervention Name(s)
William Flexion Exercises
Intervention Description
Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR).
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
0 means no pain and 10 means worst pain ever felt
Time Frame
4 weeks
Title
Flexi curve ruler
Description
to measure the lumber cure
Time Frame
4 weeks
Title
Bubble inclinometer
Description
Measure the cure
Time Frame
4 weeks
Title
King Health Questionnaire quality of life
Description
lesser score means low quality of life and higher score means better quality of life
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Males and females with age between 40-60 years Patients referred from neuro and orthopedic departments with diagnosed lumbosacral radiculopathy. Complaint of low back pain on walk, bending and after long sitting with positive slump test. Complaint of low back pain, and numbness and tingling in leg with positive SLR test Exclusion Criteria: • Lumbar Trauma Any other orthopedic and neurological conditions of hip and lumbosacral spine. Hip Fracture Malignancy
Facility Information:
Facility Name
Isra niversity
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46030
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-sarcal Radiculopathy

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